NUMBRINO
- Product NDC
- 81665-300
- 11-digit product format
- 816650300
- Labeler code
- 81665
- Product ID
- 81665-300_b722df62-ac8d-49c0-b357-c814b89471fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cocaine hydrochloride nasal
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- OMNIVIUM PHARMACEUTICALS LLC.
- Application
- NDA209575
- Marketing category
- NDA
- Marketing start
- 2024-06-19
- Substance
- COCAINE HYDROCHLORIDE
- Active strength
- 40 mg/mL
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209575-001 | NUMBRINO | COCAINE HYDROCHLORIDE | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209575-001 | 10016407 | 2037-02-07 | U-2225 | 2023-08-28 | |
| N209575-001 | 10016407 | 2037-02-07 | U-2226 | 2023-08-28 | |
| N209575-001 | 10016407 | 2037-02-07 | U-2329 | 2023-08-28 | |
| N209575-001 | 10149843 | 2037-02-07 | U-2478 | 2023-08-28 | |
| N209575-001 | 10149843 | 2037-02-07 | U-2479 | 2023-08-28 | |
| N209575-001 | 10231961 | 2037-02-07 | Drug product | 2023-08-28 | |
| N209575-001 | 10413505 | 2037-02-07 | U-3014 | 2023-08-28 | |
| N209575-001 | 10420760 | 2037-02-07 | U-2478 | 2023-08-28 | |
| N209575-001 | 10857095 | 2037-02-07 | U-3014 | 2023-08-28 | |
| N209575-001 | 10894012 | 2037-02-07 | U-3014 | 2023-08-28 | |
| N209575-001 | 10933060 | 2037-02-07 | U-2478 | 2023-08-28 | |
| N209575-001 | 10933060 | 2037-02-07 | U-3014 | 2023-08-28 | |
| N209575-001 | 10973811 | 2037-02-07 | U-3680 | 2023-08-28 | |
| N209575-001 | 11040032 | 2037-02-07 | Drug product | 2023-08-28 | |
| N209575-001 | 9867815 | 2037-02-07 | U-2225 | 2023-08-28 | |
| N209575-001 | 9867815 | 2037-02-07 | U-2226 | 2023-08-28 | |
| N209575-001 | 9867815 | 2037-02-07 | U-2227 | 2023-08-28 | |
| N209575-001 | 9867815 | 2037-02-07 | U-2329 | 2023-08-28 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | 2020-01-10 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209575-001 | NUMBRINO | 4% | SOLUTION / NASAL | RLD, RS | 2020-01-10 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10016407 | 2037-02-07 | U-2225 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10016407 | 2037-02-07 | U-2226 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10016407 | 2037-02-07 | U-2329 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10149843 | 2037-02-07 | U-2478 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10149843 | 2037-02-07 | U-2479 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10231961 | 2037-02-07 | Drug product | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10413505 | 2037-02-07 | U-3014 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10420760 | 2037-02-07 | U-2478 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10857095 | 2037-02-07 | U-3014 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10894012 | 2037-02-07 | U-3014 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10933060 | 2037-02-07 | U-2478 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10933060 | 2037-02-07 | U-3014 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 10973811 | 2037-02-07 | U-3680 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 11040032 | 2037-02-07 | Drug product | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 9867815 | 2037-02-07 | U-2225 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 9867815 | 2037-02-07 | U-2329 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 9867815 | 2037-02-07 | U-2227 | 2023-08-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N209575-001 | 9867815 | 2037-02-07 | U-2226 | 2023-08-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10016407 | 2037-02-07 | U-2225 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10016407 | 2037-02-07 | U-2226 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10016407 | 2037-02-07 | U-2329 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10149843 | 2037-02-07 | U-2478 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10149843 | 2037-02-07 | U-2479 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10231961 | 2037-02-07 | Drug product | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10413505 | 2037-02-07 | U-3014 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10420760 | 2037-02-07 | U-2478 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10857095 | 2037-02-07 | U-3014 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10894012 | 2037-02-07 | U-3014 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10933060 | 2037-02-07 | U-2478 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10933060 | 2037-02-07 | U-3014 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 10973811 | 2037-02-07 | U-3680 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 11040032 | 2037-02-07 | Drug product | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 9867815 | 2037-02-07 | U-2225 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 9867815 | 2037-02-07 | U-2329 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 9867815 | 2037-02-07 | U-2227 | 2023-08-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N209575-001 | 9867815 | 2037-02-07 | U-2226 | 2023-08-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209575-001 | 10016407 | 2037-02-07 | U-2225 | 2023-08-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209575-001 | 10016407 | 2037-02-07 | U-2226 | 2023-08-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209575-001 | 10016407 | 2037-02-07 | U-2329 | 2023-08-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209575-001 | 10149843 | 2037-02-07 | U-2478 | 2023-08-28 | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209575-001 | NCE | 2022-12-14 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N209575-001 | NP | 2023-01-10 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N209575-001 | NCE | 2022-12-14 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N209575-001 | NP | 2023-01-10 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N209575-001 | NCE | 2022-12-14 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N209575-001 | NP | 2023-01-10 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N209575-001 | NCE | 2022-12-14 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N209575-001 | NP | 2023-01-10 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N209575-001 | NCE | 2022-12-14 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N209575-001 | NP | 2023-01-10 | 782e0a99824c… |
| 2023-12-20 04:57 UTC | 2023-12 | N209575-001 | NP | 2023-01-10 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209575-001 | NP | 2023-01-10 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209575-001 | NP | 2023-01-10 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209575-001 | NP | 2023-01-10 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209575-001 | NP | 2023-01-10 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N209575-001 | NP | 2023-01-10 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N209575-001 | NCE | 2022-12-14 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N209575-001 | NP | 2023-01-10 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209575-001 | NCE | 2022-12-14 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209575-001 | NP | 2023-01-10 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N209575-001 | NCE | 2022-12-14 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N209575-001 | NP | 2023-01-10 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N209575-001 | NCE | 2022-12-14 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N209575-001 | NP | 2023-01-10 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N209575-001 | NCE | 2022-12-14 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N209575-001 | NP | 2023-01-10 | cb3db0bc1861… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NUMBRINO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| COCAINE HYDROCHLORIDE | 40 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| XH8T8T6WZH | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d724b5b4-6654-4bf5-9eed-e2c7943084ed | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc803e48-5aa8-4a87-8ab4-fcff7feb5dd5 | Product name | 1 | 20200610 |
| 8e5656e6-cd09-45b0-8d65-fbeaa5f1dc4e | Product name | 1 | 20180220 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81665-300-02 | NUMBRINO | 1 in 1 CARTON | SOLUTION | 1 | 3 | |
| 81665-300-02 | NUMBRINO | 4 mL in 1 BOTTLE, GLASS | SOLUTION | 4 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 81665-300-02 | ML - Milliliter | 81665-300 | 611db05a-e72e-4a2c-a625-dfaca0827305 | 1 | 2024-07-12 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NUMBRINO | COCAINE HYDROCHLORIDE NASAL | OMNIVIUM PHARMACEUTICALS LLC. | d724b5b4-6654-4bf5-9eed-e2c7943084ed | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | 209575 NDA209575 81665-300 |
| cocaine hydrochloride nasal | COCAINE HYDROCHLORIDE NASAL | OMNIVIUM PHARMACEUTICALS LLC. | 4e3b2f6b-1b57-40bc-872b-01c0a3c7986e | 2023-09-24 | Boxed warning, Warnings, Adverse reactions | 209575 NDA209575 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1995288 | cocaine hydrochloride 4 % Nasal Solution | PSN | d724b5b4-6654-4bf5-9eed-e2c7943084ed | 3 |
| 2272608 | NUMBRINO 4 % (40 MG/ML) Nasal Solution | PSN | d724b5b4-6654-4bf5-9eed-e2c7943084ed | 3 |
| 2272608 | cocaine hydrochloride 40 MG/ML Nasal Solution [Numbrino] | SBD | d724b5b4-6654-4bf5-9eed-e2c7943084ed | 3 |
| 1995288 | cocaine hydrochloride 40 MG/ML Nasal Solution | SCD | d724b5b4-6654-4bf5-9eed-e2c7943084ed | 3 |
| 1995288 | cocaine hydrochloride 4 % Nasal Solution | SY | d724b5b4-6654-4bf5-9eed-e2c7943084ed | 3 |
| 2272608 | Numbrino 40 MG/ML Nasal Solution | SY | d724b5b4-6654-4bf5-9eed-e2c7943084ed | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 81665-300-02 | 81665030002 | 1 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS | 2024-06-19 | No | No | Current |